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The Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003

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Duties of the Department in relation to applications for consent to market

23.—(1) Following receipt of an application for a consent to market genetically modified organisms the Department shall –

(a)inform the applicant in writing of the date of receipt of the application;

(b) forward to the Commission and to the competent authorities of the other Member States a summary of that application in the format established by the Commission under Article 13(2)(h) of the Deliberate Release Directive;

(c)examine the application for its conformity with the requirements of the Order and of these Regulations and, if necessary, request the applicant to supply additional information;

(d)before the end of a period of 90 days beginning with the day on which it received the application either –

(i)send to the applicant an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should be permitted to be marketed and under which conditions, or

(ii)refuse the application, stating reasons for its decision, supported by an assessment report prepared in accordance with Schedule 4 which indicates that the genetically modified organisms should not be marketed, and

(e)once it is satisfied it conforms to the requirements prescribed in regulation 16, and no later than when it sends its assessment report in accordance with paragraph (d), forward a copy of the application to the Commission.

(2) The Department shall forward to the Commission –

(i)its assessment report,

(ii)any further information it has received from the applicant pursuant to the service of a notice under Article 8(6) of the Order,

(iii)any additional information on which it has based its assessment report,

in the circumstances described in paragraph (1)(d)(i), before the end of a period of 90 days beginning with the day on which it received the application and, in the circumstances described in paragraph (1)(d)(ii), no sooner than 15 days from the date it sent the assessment report to the applicant and no later than 105 days from the date it received the application.

(3) The 90 day periods prescribed in paragraphs (1) and (2) shall not include any period beginning with the day on which the Department gives notice in writing under Article 8(6) of the Order that further information in respect of the application is required and ending on the day on which that information is received by the Department.

(4) Where the Department intends to submit to the Commission an assessment report which indicates that the genetically modified organisms to which an application relates should be permitted to be marketed, it shall first consult the Executive and shall not forward its favourable opinion on the application as it relates to the protection of human health where the Executive has informed it that it does not fulfil the requirements of the Order and of these Regulations.

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